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CTRI Number  CTRI/2024/11/076563 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between churna Pinda sweda and yoga therapy in chronic low back pain.  
Scientific Title of Study   Comparative study between churna pinda Sweda with Yoga therapy and Yoga therapy alone in chronic low back pain: A prospective randomized open-label study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasanta Kumar Sahoo 
Designation  Senior Medical Officer Ayurveda 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of AYUSH AIIMS, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7240734331  
Fax    
Email  ayush_prasanta@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Prasanta Kumar Sahoo 
Designation  Senior Medical Officer Ayurveda 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of AYUSH AIIMS, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7240734331  
Fax    
Email  sahooprasanta78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prasanta Kumar Sahoo 
Designation  Senior Medical Officer Ayurveda 
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of AYUSH AIIMS, Bhubaneswar


ORISSA
751019
India 
Phone  7240734331  
Fax    
Email  ayush_prasanta@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua Patrapada Odisha 751019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasanta Kumar Sahoo  AIIMS Hospital  Room. No 5, Ayurveda Unit, Department of AYUSH AIIMS Bhubaneswar Hospital
Khordha
ORISSA 		 7240734331

ayush_prasanta@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: Charak Samhita Sutra Stan chapter 14, Procedure details: Churna Pinda Sweda Duration: 15 minutes once daily)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Willingness to participate in research
2. Primary complaint of low back pain for more than three months.
3. Age should be between 18 years to 60 years.
4. Patient whose Numeric pain rating score (NPRS) ≥ 3
 
 
ExclusionCriteria 
Details  1. Congenital spinal disorders
2. Chronic systemic illness
3.H/O Previous surgery of the spine
4. Patient with spondylolisthesis, fracture, osteoporosis, etc.
5. Malignant bone disorders
6. Evidence of radiculopathy
7. Severe psychiatry disorder
8. Pregnant women
9. Infectious disease.
10. Patients with h/o taking analgesics should be excluded.
11. Patients with h/o sensory or motor deficit should be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in low back pain intensity score from baseline for Churna Pinda Sweda (CPS) with Yoga therapy after 30 days of intervention.
2.Change in low back pain intensity score from baseline for Yoga therapy after 30 days of interventions.
3.To Compare the low back pain intensity score for Churna Pinda Sweda (CPS) with Yoga therapy and Yoga therapy alone after 30 days of interventions.
 		 1.Low back pain intensity score at baseline, after 15 days and 30 days of treatment.

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in disability score from baseline for Churna Pinda Sweda (CPS) with Yoga therapy
2.Change in disability score from baseline for Yoga therapy.
3.To Compare the disability score between Churna Pinda Sweda (CPS) with Yoga therapy and Yoga therapy alone.
 		 Assessment will be done after completion of 30 days of treatment 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be provided if requested through proper channel and after approval from the competent authority of the study site and sponser of this project.

  6. For how long will this data be available start date provided 01-05-2026 and end date provided 01-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This is a randomized open label clinical study will be conducted in the Department of AYUSH, AIIMS, Bhubaneswar for chronic low back pain (CLBP) patients aged between 18 to 60 years from both sex with intervention of Churna Pinda Sweda (CPS) and Yoga therapy. Blocks randomization will be selected for enrolment of the participants. Patients recruited in group A will be treated with CPS for 15 days and continue Yoga for 30 days. And in group B, patients will be advised to continue Yoga for 30 days. Assessment will be done after completion of 30 days of treatment. The primary objective will be to compare the effectiveness of CPS with Yoga therapy and Yoga therapy alone in CLBP. Primary outcomes will be change in low back pain intensity score from baseline for CPS with Yoga therapy, and change in low back pain intensity score from baseline for Yoga therapy, to compare the low back pain intensity score for CPS with Yoga therapy and Yoga therapy alone. Secondary outcomes will be change in disability score from baseline for CPS with Yoga therapy, change in disability score from baseline for Yoga therapy, and to compare the disability score between CPS with Yoga therapy and Yoga therapy alone. The total duration of study will be 12 months. 
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